Safety and Efficacy Study of Misoprostol Vaginal Insert for Induction of Labour
The primary objective of the study was assessment of the efficacy of four dose reservoirs (25 mcg, 50 mcg, 100 mcg, 200 mcg) of intravaginal controlled release misoprostol administered for up to 24 hours. Efficacy was measured in terms of time from insert placement to vaginal delivery.
Approximately 20% of pregnant women require medical intervention to induce labour for reasons including post-date pregnancy, pre-eclampsia, maternal diabetes, premature rupture of the membranes and intra-uterine fetal growth retardation. There are two fundamental changes that characterise pre-labour preparation for delivery: sensitisation of the myometrium to produce contractions, and ripening (softening and dilation) of the cervix. Prostaglandins (PG) are fundamental to both of these changes, and several forms have been used to successfully induce labour. Dinoprostone (PGE2) is an example of a cervical ripening agent that is available in gel and tablet form and has a proven record of successful cervical ripening in this population. Dinoprostone is also available in a controlled release vaginal delivery system, which is manufactured by Controlled Therapeutics (Scotland) a subsidiary of Cytokine PharmaSciences, Inc., King of Prussia, PA, USA.
Another synthetic prostaglandin that has been shown to be an effective cervical ripener and labour inducer is misoprostol. Oral tablets are broken into fragments and used intravaginally to ripen the cervix and induce labour Due to the disadvantages of existing cervical ripeners (delivery of bolus doses, freezer or refrigerated storage, lack of efficacy in labour induction), and due to safety concerns with the off-label use of oral misoprostol tablet fragments, Controlled Therapeutics has developed a controlled release vaginal delivery system similar to its marketed dinoprostone product but containing misoprostol.
This study examines four dose strengths of the misoprostol vaginal insert in women who need to have their labours induced.
Allocation: Randomized, Control: Dose Comparison, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Misoprostol vaginal insert 25 mcg, Misoprostol vaginal insert 50 mcg, Misoprostol vaginal insert 100 mcg, Misoprostol vaginal insert 200 mcg
Birmingham Women's Hospital
Results (where available)
- Source: http://clinicaltrials.gov/show/NCT00346840
- Information obtained from ClinicalTrials.gov on July 15, 2010
Medical and Biotech [MESH] Definitions
Collection of pooled secretions of the posterior vaginal fornix for cytologic examination.
An incision of the posterior vaginal wall and a portion of the pudenda which enlarges the vaginal introitus to facilitate delivery and prevent lacerations.
A synthetic analog of natural prostaglandin E1. It produces a dose-related inhibition of gastric acid and pepsin secretion, and enhances mucosal resistance to injury. It is an effective anti-ulcer agent and also has oxytocic properties.
Tumors or cancer of the VAGINA.
Pathological processes of the VAGINA.
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